ImmunityBio Slides Following FDA Refusal-to-File Letter

Dow Jones

May 06

By Josh Beckerman

Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder-cancer treatment Anktiva.

The stock was down 19%, to $2.04, midday Monday and has fallen about 20% this year. The intraday low was $2.

The company said it requested an urgent meeting with the FDA. It said the letter was inconsistent from the unanimous guidance and encouragement it received from FDA leadership at a January meeting, and that a delay is harmful to patients who have a disease with a high risk of morbidity and mortality.

ImmunityBio submitted the application for use of Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. The drug was approved in April 2024 for certain bladder-cancer patients.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

May 05, 2025 13:05 ET (17:05 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

At the request of the copyright holder, you need to log in to view this content

LOGIN / SIGN UP

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www-web.itiger.com/news/2533538665"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2533538665\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2533538665?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-05-06 01:05","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2533538665","market":"sh","top_or_hot":-1,"title":"ImmunityBio Slides Following FDA Refusal-to-File Letter","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Josh Beckerman \n</p>\n<pre>\n \n</pre>\n<p>\n  Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder-cancer treatment Anktiva. \n</p>\n<p>\n  The stock was down 19%, to $2.04, midday Monday and has fallen about 20% this year. The intraday low was $2. \n</p>\n<p>\n  The company said it requested an urgent meeting with the FDA. It said the letter was inconsistent from the unanimous guidance and encouragement it received from FDA leadership at a January meeting, and that a delay is harmful to patients who have a disease with a high risk of morbidity and mortality. \n</p>\n<p>\n  ImmunityBio submitted the application for use of Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. The drug was approved in April 2024 for certain bladder-cancer patients. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 05, 2025 13:05 ET (17:05 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>ImmunityBio Slides Following FDA Refusal-to-File Letter</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nImmunityBio Slides Following FDA Refusal-to-File Letter\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time\">2025-05-06 01:05</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Josh Beckerman \n</p>\n<pre>\n \n</pre>\n<p>\n  Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder-cancer treatment Anktiva. \n</p>\n<p>\n  The stock was down 19%, to $2.04, midday Monday and has fallen about 20% this year. The intraday low was $2. \n</p>\n<p>\n  The company said it requested an urgent meeting with the FDA. It said the letter was inconsistent from the unanimous guidance and encouragement it received from FDA leadership at a January meeting, and that a delay is harmful to patients who have a disease with a high risk of morbidity and mortality. \n</p>\n<p>\n  ImmunityBio submitted the application for use of Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. The drug was approved in April 2024 for certain bladder-cancer patients. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 05, 2025 13:05 ET (17:05 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IBRX","symbol_name":"ImmunityBio, Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2533538665","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2533538665","pubTimestamp":1746464700,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder-cancer treatment Anktiva.The stock was down 19%, to $2.04, midday Monday and has fallen about 20% this year. The intraday low was $2.The company said it requested an urgent meeting with the FDA. It said the letter was inconsistent from the unanimous guidance and encouragement it received from FDA leadership at a January meeting, and that a delay is harmful to patients who have a disease with a high risk of morbidity and mortality.ImmunityBio submitted the application for use of Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. The drug was approved in April 2024 for certain bladder-cancer patients.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IBRX":"ImmunityBio, Inc.","BK4139":"生物科技"},"translate_title":"FDA拒绝备案信后ImmunityBio股价下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IBRX":0.9},"content_text":"By Josh Beckerman \n\n\n \n\n\n  Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder-cancer treatment Anktiva. \n\n\n  The stock was down 19%, to $2.04, midday Monday and has fallen about 20% this year. The intraday low was $2. \n\n\n  The company said it requested an urgent meeting with the FDA. It said the letter was inconsistent from the unanimous guidance and encouragement it received from FDA leadership at a January meeting, and that a delay is harmful to patients who have a disease with a high risk of morbidity and mortality. \n\n\n  ImmunityBio submitted the application for use of Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. The drug was approved in April 2024 for certain bladder-cancer patients. \n\n\n \n\n\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 05, 2025 13:05 ET (17:05 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}